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Neonatal Sepsis clinical trials

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NCT ID: NCT04842786 Recruiting - Clinical trials for Late-Onset Neonatal Sepsis

Topical Coconut Oil Application and Incidence of Sepsis in Neonates

Start date: May 15, 2021
Phase: N/A
Study type: Interventional

The randomized control trial aims to determine the effect of twice daily application of a commonly used coconut oil to the skin of neonates in the neonatal intensive care setting on the rate of late onset sepsis versus a no treatment control.

NCT ID: NCT04742582 Recruiting - Neonatal Sepsis Clinical Trials

Potential Protective Effect of a Formula Supplemented With Fermented Matrices on the Risk of Developing Neonatal Sepsis

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

This is a multicenter, randomized, double-blind, placebo controlled trial, with parallel groups and reference group. The aim of the study was to evaluate the hypothesis that an immunonutritional strategy, based on use of Lactobacillus paracasei CBA L74-fermented formula, prevents or limits the development of late-onset-sepsis in preterm infants.

NCT ID: NCT04732026 Recruiting - Clinical trials for Group B Strep Infection

Serocorrelate of Protection Against GBS (PREPARE WP3)

Start date: April 1, 2020
Phase:
Study type: Observational

A multicentre, international case-control study to develop a biobank of sera from 150 cases of serotype III GBS disease and associated clinical information from seven countries (Malawi, Uganda, UK, the Netherlands, Italy and France), with 3:1 (450) serotype matched healthy controls.

NCT ID: NCT04717037 Recruiting - Sepsis Clinical Trials

Olive Oil Massage Effect for Reduction of Preterm Sepsis (OMEPS)

OMEPS
Start date: September 1, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

The OMEPS trial is a randomized clinical trial in the western region of Saudi Arabia. Conducted to assess the safety and feasibility of olive oil as massage for preterm infants and if associated with reduced risk of Late-Onset sepsis.

NCT ID: NCT04528251 Recruiting - Neonatal Sepsis Clinical Trials

Comparison of the Effectiveness of Two Different Antibiotic Regimens of the Treatment of Pregnant Women With Preterm Rupture of Membranes

Start date: September 1, 2020
Phase:
Study type: Observational

There is no consensus around the world on the treatment of preterm rupture of membranes, which is one of the important causes of early neonatal sepsis and one of the common causes of prematurity. Different countries, hospitals and physicians can determine different treatment approaches. There is very little scientific data on the benefit of commonly used treatment regimens other than experience. In this study, scientific results will be obtained by comparing the efficacy of treatments (Sulbactam ampicillin or azithromycin ampicillin) in two different hospitals (Hacettepe University Perinatology Clinic and Ankara City Hospital Perinatology Clinic), and it will be shown which treatment regimen reduces early neonatal sepsis and inflammation better. Some samples (vaginal IL-6, vaginal-cervical swab samples for atypical bacteria, cervical swab samples for direct microscopy, serum IL-6) will be taken from pregnant women who develop membrane rupture and these samples will be used as initial inflammation markers. Each physician will decide on the treatment of his own patient, there will be no intervention in the treatment of the patient within the scope of the research. Patients will continue their routine follow-up after receiving their treatment. When the delivery occurs, the level of IL-6 in the cord blood will be examined with other inflammation markers (procalcitonin, crp, complete blood count), and the neonatal inflammation status of the baby will be determined. The low inflammation markers detected in the babies of pregnant women with high initial inflammation values will be compared and it will be determined which treatment is more effective. At the same time, routine neonatal intensive care follow-ups of these babies will be continued and treatment efficiency in terms of early neonatal sepsis will be determined. This study will present scientific data on which treatment is effective in the literature and will guide international treatment guidelines. At the same time, preterm rupture of membranes will show which bacterial agent plays a more role in the etiology and which of the inflammation markers have more sensitivity and specificity, as well as the success of the treatment, which is the subject of the study. The routine use of some examinations (such as cervical PCR) performed before the treatment begins, is a guide in the selection of agent-specific treatment and may shorten the unnecessary drug use and hospital stay; The management of patients may vary according to the initial inflammation parameters. Physicians evaluating the results of this study can evaluate the risk of their babies in terms of early neonatal sepsis according to the initial inflammation values of their patients, and increase and decrease the length of hospital stay.

NCT ID: NCT04455022 Recruiting - Neonatal Sepsis Clinical Trials

The Volume of Blood Submitted for Culture in Neonates - a Multicentre Quality Improvement Initiative.

VOB4C
Start date: May 10, 2022
Phase:
Study type: Observational

The study will examine if introducing the practice of checking the volume of blood culture samples in neonates by bedside weighing will improve the sensitivity of the test and increase confidence in negative results affecting the rate of extended antibiotic treatment in neonates with negative blood cultures.

NCT ID: NCT04388293 Recruiting - Clinical trials for Antimicrobial Resistance

Using Antibiotics Wisely - An Antimicrobial Stewardship Program

Start date: January 1, 2020
Phase:
Study type: Observational [Patient Registry]

There are significant variations in antimicrobial consumption across Canadian Neonatal Intensive Care Units (NICUs). Inappropriate and overuse of antibiotics can result in antimicrobial resistance and adverse outcomes among vulnerable neonatal populations. There are limited data on broad-spectrum antimicrobial use, multi-drug resistant organisms (MDRO) prevalence, and effective NICU-specific antimicrobial stewardship strategies. The aim of this study is to develop and implement NICU-specific antimicrobial stewardship strategies at both national and individual unit levels to promote optimal antimicrobial use and decrease the incidence of MDROs.

NCT ID: NCT04152980 Recruiting - Clinical trials for Neonatal Late Onset Sepsis

Pentoxifylline Dose Optimization in Neonatal Sepsis

Start date: January 12, 2020
Phase: Phase 3
Study type: Interventional

Sepsis is a very important cause of death and morbidity in preterm infants. There are strong indications that preterm neonates with sepsis could benefit, next to antibiotics, from treatment with pentoxifylline (PTX). Knowledge about optimal dosing is however limited. This study is a dose optimization study using a step-up and step-down model. In order to find the optimal dose, the infusion of pentoxifylline in different dosages will be studied, next to antibiotics with 3 patients per dosage. After the dose optimization study an additional cohort of 10 patients will be treated with the found dosage as a validation of the dose.

NCT ID: NCT04110418 Recruiting - Neonatal Sepsis Clinical Trials

Methylene Blue Versus Vasopressin Analogue for Treatment of Septic Shock in Preterm Neonate

Start date: February 19, 2019
Phase: Phase 2
Study type: Interventional

A randomized, prospective study comparing methylene blue versus terlipressin in treatment of catecholamines resistant shock in preterm neonate

NCT ID: NCT03997266 Recruiting - Clinical trials for Microbial Colonization

NICU Antibiotics and Outcomes Trial

NANO
Start date: August 5, 2020
Phase: Phase 4
Study type: Interventional

The goal of the NANO trial is to study the longstanding clinical practice of empirically administering intravenous antibiotics to extremely low birthweight (ELBW) infants in the first days of life. In this 802-subject multicenter placebo-controlled randomized clinical trial, the hypothesis to be tested is that the incidence of adverse outcomes is higher in babies receiving empiric antibiotics (EA) in the first week of life compared to babies receiving placebo. The study targets a population of ELBW infants in whom the clinical decision to use or not use EA is currently most challenging -- infants that are clinically stable that did not have a known exposure to intraamniotic infection and were not born preterm for maternal indications. The primary outcome is the composite outcome of late-onset sepsis (LOS), necrotizing enterocolitis (NEC), or death during the index hospitalization. Secondary safety outcomes will include total antibiotic days, days to full enteral feedings, and common morbidities in preterm infants that have previously been linked to EA, e.g. retinopathy of prematurity and bronchopulmonary dysplasia. Weight and length z-score, and head circumference, are standard measures to be collected weekly by clinical team per a standardized protocol.